Intravenous Dilution Guidelines

Pantoprazole (Protonix ®)

The authors make no claims of the accuracy of the information contained
herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the
preparation of this document shall be liable for any special,
consequential, or exemplary damages resulting in whole or part from any
user's use of or reliance upon this material. PLEASE
READ THE DISCLAIMER CAREFULLY BEFORE
ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE
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Stability / Miscellaneous

INDICATIONS AND USAGE
-Treatment of Gastroesophageal Reflux Disease Associated With a History
of Erosive Esophagitis:
PROTONIX I.V. for Injection is indicated for short-term treatment (7 to
10 days) of patients with gastroesophageal reflux disease (GERD) and a
history of erosive esophagitis.

Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome:
PROTONIX I.V. for Injection is indicated for the treatment of
pathological hypersecretory conditions associated with Zollinger-Ellison
Syndrome or other neoplastic conditions.

DOSAGE AND ADMINISTRATION
PROTONIX I.V. for Injection may be administered intravenously through a
dedicated line or through a Y-site. The intravenous line should be
flushed before and after administration of PROTONIX I.V. for Injection
with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection,
USP, or Lactated Ringer's Injection, USP. When administered through a
Y-site, PROTONIX I.V. for Injection is compatible with the following
solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection,
USP, or Lactated Ringer's Injection, USP.

Midazolam HCl has been shown to be incompatible with Y-site
administration of PROTONIX I.V. for Injection. PROTONIX I.V. for
Injection may not be compatible with products containing zinc. When
PROTONIX I.V. for Injection is administered through a Y-site,
immediately stop use if precipitation or discoloration occurs.

Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to and during administration whenever
solution and container permit.

Treatment with PROTONIX I.V. for Injection should be discontinued as
soon as the patient is able to be treated with PROTONIX Delayed-Release
Tablets. Also, data on the safe and effective dosing for conditions
other than those described in INDICATIONS AND USAGE, such as
life-threatening upper gastrointestinal bleeds, are not available.
PROTONIX I.V. 40 mg once daily does not raise gastric pH to levels
sufficient to contribute to the treatment of such life-threatening
conditions.

Parenteral routes of administration other than intravenous are not
recommended.

No dosage adjustment is necessary in
patients with renal impairment, hepatic impairment, or for elderly
patients. Doses higher than 40 mg/day have not been
studied in hepatically-impaired patients. No dosage adjustment is
necessary in patients undergoing hemodialysis.

Treatment of Gastroesophageal Reflux Disease Associated With a
History of Erosive Esophagitis
The recommended adult dose is 40 mg pantoprazole given once daily by
intravenous infusion for 7 to 10 days. Safety and efficacy of PROTONIX
I.V. for Injection as a treatment of patients with GERD and a history
of erosive esophagitis for more than 10 days have not been demonstrated
(see INDICATIONS AND USAGE ).

Fifteen Minute Infusion
PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9%
Sodium Chloride Injection, USP, and further diluted (admixed) with 100
mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP,
or Lactated Ringer's Injection, USP, to a final concentration of
approximately 0.4 mg/mL. The reconstituted solution may be stored for
up to 6 hours at room temperature prior to further dilution. The
admixed solution may be stored at room temperature and must be used
within 24 hours from the time of initial reconstitution. Both the
reconstituted solution and the admixed solution do not need to be
protected from light.

PROTONIX I.V. for Injection admixtures should be administered
intravenously over a period of approximately 15 minutes at a rate of
approximately 7 mL/min.

Two Minute Infusion
PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9%
Sodium Chloride Injection, USP, to a final concentration of
approximately 4 mg/mL. The reconstituted solution may be stored for up
to 24 hours at room temperature prior to intravenous infusion and does
not need to be protected from light. PROTONIX I.V. for Injection should
be administered intravenously over a period of at least 2 minutes.

Pathological Hypersecretion Associated with Zollinger-Ellison
Syndrome
The dosage of PROTONIX I.V. for Injection in patients with pathological
hypersecretory conditions associated with Zollinger-Ellison Syndrome or
other neoplastic conditions varies with individual patients. The
recommended adult dosage is 80 mg q12h. The frequency of dosing can be
adjusted to individual patient needs based on acid output measurements.
In those patients who need a higher dosage, 80 mg q8h is expected to
maintain acid output below 10 mEq/h. Daily doses higher than 240 mg or
administered for more than 6 days have not been studied. (See package
insert Clinical Studies section.) Transition from oral to I.V. and from
I.V. to oral formulations of gastric acid inhibitors should be
performed in such a manner to ensure continuity of effect of
suppression of acid secretion. Patients with Zollinger-Ellison Syndrome
may be vulnerable to serious clinical complications of increased acid
production even after a short period of loss of effective inhibition.

Fifteen Minute Infusion
Each vial of PROTONIX I.V. for Injection should be reconstituted with
10 mL of 0.9% Sodium Chloride Injection, USP. The contents of the two
vials should be combined and further diluted (admixed) with 80 mL of 5%
Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or
Lactated Ringer's Injection, USP, to a total volume of 100 mL with a
final concentration of approximately 0.8 mg/mL. The reconstituted
solution may be stored for up to 6 hours at room temperature prior to
further dilution. The admixed solution may be stored at room
temperature and must be used within 24 hours from the time of initial
reconstitution. Both the reconstituted solution and the admixed
solution do not need to be protected from light.

PROTONIX I.V. for Injection should be administered intravenously over a
period of approximately 15 minutes at a rate of approximately 7 mL/min.

Two minute Infusion
PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9%
Sodium Chloride Injection, USP, per vial to a final concentration of
approximately 4 mg/mL. The reconstituted solution may be stored for up
to 24 hours at room temperature prior to intravenous infusion and does
not need to be protected from light. The total volume from both vials
should be administered intravenously over a period of at least 2
minutes.

HOW SUPPLIED
PROTONIX® I.V. (pantoprazole sodium) for Injection is supplied as a
freeze-dried powder containing 40 mg of pantoprazole per vial.

Disclaimer

The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical
judgment. Neither GlobalRPh Inc. nor any other party involved in the
preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER
CAREFULLY
BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU
AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.